Experience includes - Expansion of Mesenchymal stem cells (MSCs) and Final Product formulation for Translational Therapeutic protocols.- Writing SOPs, BRs, and Forms- Assist in large animal protocol.- Assist in cGMP laboratories maintenance.

- Study, Evaluate, and Establish manufacturing procedures for Tregs- Coordinate with various suppliers to obtain supplies for cGMP production.- Writing Batch Records, SOPs, and Forms.- Coordinate QC activities (Cell Count/Viability, Flow Cytometry, Sterility, Functional, Endotoxin, Mycoplasma, and etc.) - Assist in writing CMC and FDA submission- Main operator for validation runs and clinical manufacturing runs.- Main operator for final product formulation for infusions- Coordinating activities with offsite collaborators (UT health and Massachusetts General Hospital)- cGMP – Sepax 2 RM (GE Healthcare/Biosafe), CliniMACS (Miltenyi), Teromo BCT Quantum, CFR (Thermofisher), Tregs isolation and expansions – small, mid, and large scale (Research and Clinical), and Q-Pulse QA system, Cryoport sample shipping.

Managing ISO7/8 cGMP Laboratory. Coordinating various activities for GLP/cGMP phase I Clinical Translational Projects.* Ordering Supplies, Material Control via CoA, Environmental Survey (Surface Viable, Air Viable, Air Particles Counts), Sterile Process (Depyrogenation, Autoclave, Ethylene Oxide Gas Sterilization, RO Water Sanitation, Endotoxin testing). Small volume sterile vialing and Lyophilization* Writing Projects Batch Records and Equipment SOPs * Coordinating various translational projects manufacturing in cGMP facility* Translational Projects manufacturing:mRNA for therapeutic, Collagen Membranes for Bone Fracture, Injectable Silica nanoparticles for drug delivery, Polymer conjugated Doxorubicin iNPG/pDox for breast cancer

"I was tasked to bring a start-up reference lab to meet clinical laboratory qualification to provide pharmacogenetics testing. This included planning and coordinating the test validation protocol with a laboratory director. I helped in hiring and trained laboratory staffs. I worked on laboratory QA/QC plan to obtain CLIA certification for the laboratory. My tasks included putting together laboratory procedures for sample processing, results analysis and reporting. I created batch records and spreadsheets to manage more than 2880 SNPs data points. I validated buccal swabs as an alternative test specimen for pharmacogenetics testing. I oversaw the management of various laboratory equipment and coordinated services and maintenance schedules."• Established laboratory setting, test methods validation, QA/QC and compliances program for CLIA accreditation• Overseeing equipment purchases and checking for functionality.• Maintaining and ordering laboratory supplies • Training laboratory staff• Tests Validation - SNP's analysis for Pharmacogenetics Testing (CYP1A, CYP2C9, CYP2C19, CYP2D6, CYP3A4, CYP3A5, and risk factors)• Equipment - DNA extraction (MagMax - LifeTechnologies), OpenArray Genotyping for SNP detection and gene del/dup (QuantStudio 12K flex, ViiA7 - LifeTechnologies), SNP's analysis (TranslationalSoftware)

As a Clinical Laboratory Supervisor, I ensured that clinical samples were processed to obtain optimal DNA quantity and quality for various clinical tests. We achieved a success rate of over 99% in obtaining high-quality DNA from these samples.I established a DNA core laboratory for the Medical Genetics Laboratory and served as a team leader at the PCR Sequencing station, where I was responsible for setting up PCR for all sequencing tests.As a Research Assistant, I conducted point mutation analysis for Cystic Fibrosis on 70 to 150 samples per week, generating over 5,000 data points.• DNA extraction - Blood, Prenatal (Direct Amniotic Fluids, Direct CVS, Culture Amniotic Fluid, Culture CVS), Tissues (Fresh, Frozen, FFPE, Bone Marrow, Slides), Saliva, and Buccal Swaps.• Performed PCRs/Sequencing on clinical DNA samples for Diagnostic Sequencing Tests.• Cystic Fibrosis - ASO hybridization (37 Mutations), Sequenom - (MALDI - TOF) Mass Spectrometry (51 mutation), • Clinical Applications – PCR, (MALDI-TOF) Mass Spectrometry, GeneMapper (DMD-STR, MSI), GeneMarker (MLPA), PureGene / AutoPure (DNA extraction), QiaSymphony (DNA extraction), Chemagen (DNA extraction) ABI – 3730xl DNA Analyzer. PyroSeq (Small Diseases)• Maintained QA/QC program according to College of American Pathologists guideline.

"My job was to perform QC tests on restriction and polymerase enzymes. I was trained to perform various assays and test methodologies. The test results were used to determine the units and functionality of the enzymes prior to release to customers."• Performed testing of Restriction Enzymes, Modifying Enzymes (including DNA and RNA polymerase, Reverse Transcriptase, Proteases), and Protein Ladders and Standards• QC Assays: PCR/RT PCR, enzymes specific functional assay, units determination assay (measuring the rate of digestion, incorporation, hydrolyzation, catalyzation of DNA, RNA and nucleotides), contamination assay (ribonuclease, exonuclease, and endonuclease), protein concentration, agarose gel electrophoresis• Involved in assay developments, protocol improvements, troubleshooting, and training• GMP (Good Manufacturing Practice) and Radiation Safety trained

"I was a medical laboratory specialist in the U.S.Army. USAMRIID specialized in research and detection of biological agents. I was trained to perform various laboratories techniques and protocols." • Performed PCR/RT-PCR, RNA/DNA extraction from tissues, cells, and bacteria, cloning for gene expression.• Performed protein purification of C. botulinum for immunologic assays. Experienced in column Chromatography - Hydrophobic Interaction, Ion Exchange, Gel Filtration, and affinity. Performed western/southern blot, gel electrophoresis, coomasie/silver stain. Prepared media and reagents used in various protocols• Produced, purified, and quantified Hybridoma monoclonal abs.• Performed Immunohistochemistry to assist in Cholera Toxin and effects on immune system of mice studies. Performed immunization of animals, obtaining tissues samples, preparing tissues slides, abs. staining analysis